Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 2:46 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT01333059
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01333059
Study Brief: Cycling of Sedative Infusions in Critically Ill Pediatric Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Group In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol. 0 None 2 14 7 14 View
Control Group In this arm, midazolam and fentanyl were administered during cycling. At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each. Dosing was done per standard of care and not prescribed per protocol. 1 None 1 11 2 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Graft vs Host Disease None Immune system disorders None View
Cardiomyopathy None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
FiO2 increased None Surgical and medical procedures None View